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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE)
Generic Namecoronary drug-eluting stent
Applicant
Boston Scientific Corp.
one scimed place
maple grove, MN 55311-1566
PMA NumberP030025
Date Received06/19/2003
Decision Date03/04/2004
Withdrawal Date 12/06/2018
Product Code NIQ 
Docket Number 04M-0403
Notice Date 09/08/2004
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Recalls CDRH Recalls
Approval Order Statement 
APPROVAL FOR THE TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE). THE DEVICE IS INDICATED FOR IMPROVING LUMINAL DIAMETER FOR THE TREATMENT OF DE NOVO LESIONS <28 MM IN LENGTH IN NATIVE CORONARY ARTERIES >= 2.5 TO <= 3.75 MM IN DIAMETER.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S050 S061 S046 S025 S045 S023 S079 S056 
S032 S031 S022 S003 S077 S076 S075 S063 S055 
S074 S072 S071 S070 S068 S067 S066 S054 S030 
S029 S090 S089 S088 S065 S027 S019 S058 S026 
S018 S084 S064 S083 S053 S040 S082 S057 S038 
S037 S036 S034 S012 S011 S052 S081 S098 S097 
S096 S094 S095 S101 S100 S099 S092 S051 S080 
S033 S005 S024 S004 S044 S091 S060 S002 S078 
S043 S021 S001 S069 S059 S049 S042 S028 S020 
S087 S086 S085 S017 S016 S015 S041 S014 S039 
S013 S062 S047 S035 S010 S008 S007 S006 S093 
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